SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 71335754 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Injury (2348)
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Event Date 04/01/2019 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed due to stiffening.Cup, poly, stem and head were removed.
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Manufacturer Narrative
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It was reported that a revision surgery was performed due to stiffening.The associated oxinium femoral head, r3 acetabular liner and anthology porous femoral component standard offset were not returned for evaluation.Thus a product evaluation could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The clinical evaluation noted the provided x-rays do not indicate a reason for the reported stiffness.Based on the information provided the reported pain and stiffening was due to the stem being loose.It was communicated that the stem had no bony ingrowth, which surgeon thought that polar stem might have been an option due to patients bone quality.The future impact to the patient beyond the revision cannot be determined.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
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